What the label lists and what reports show
Datopotamab deruxtecan side effects
Datopotamab deruxtecan's FDA label: “The most common adverse reactions (≥20%), including laboratory abnormalities, in patients with: EGFR-mutated NSCLC were stomatitis, nausea, alopecia, fatigue, decreased hemoglobin, decreased lymphocytes, constipation, increased calcium, increased AST …” FAERS holds 639 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is stomatitis (103 reports).
- No generic listed
Check it at the source: the datopotamab deruxtecan FDA label on DailyMed (effective May 27, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of DATROWAY?DATROWAY can cause serious side effects, including: See " What is the most important information I should know about DATROWAY? " The most common side effects of DATROWAY when used in adults with EGFR-mutated NSCLC include: nausea hair loss tiredness decreased red blood cell counts decreased white blood cell counts constipation increased blood levels of calcium increased blood levels of liver enzymes increased levels of enzyme called lactate dehydrogenase in the blood muscle and joint pain decreased appetite rash The most common side effects of DATROWAY when used in adults with TNBC include: increased levels of digestive enzyme (amylase) in the blood nausea hair loss decreased red blood cell counts decreased white blood cell counts constipation decreased blood levels of calcium tiredness increased blood levels of liver enzymes dry eye an eye problem called keratitis. […]
Source: FDA drug label, Daiichi Sankyo Inc., effective May 27, 2026 (SPL set 2950227c-6230-4ca4-a135-46e44d9424a0), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%), including laboratory abnormalities, in patients with: EGFR-mutated NSCLC were stomatitis, nausea, alopecia, fatigue, decreased hemoglobin, decreased lymphocytes, constipation, increased calcium, increased AST, decreased white blood cell count, increased lactate dehydrogenase, musculoskeletal pain, decreased appetite, increased ALT, and rash.
Table 4: Adverse Reactions (≥10%) in Patients with Locally Advanced or Metastatic EGFR-Mutated NSCLC Who Received DATROWAY in TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01
| Reaction | Adverse Reaction All Grades % | DATROWAY N=125 Grades 3 or 4 % |
|---|---|---|
| Stomatitis Includes other related terms | 71 | 9 |
| Nausea | 50 | 0 |
| Constipation | 31 | 0 |
| Vomiting | 16 | 0.8 |
| Diarrhea | 12 | 0 |
| Alopecia | 49 | 0 |
| Rash | 20 | 0.8 |
| Pruritus | 12 | 0 |
| Fatigue Includes fatigue, asthenia, and malaise | 42 | 6 |
| Musculoskeletal pain | 22 | 0.8 |
| Decreased appetite | 20 | 1.6 |
| COVID-19 | 19 | 2.4 |
| Cough | 18 | 0 |
| Dyspnea | 11 | 2.4 |
| Dry eye | 13 | 0 |
| Keratitis Includes corneal disorder, corneal erosion, keratitis, punctate keratitis, and… | 12 | 2.4 |
| Infusion-related reaction | 13 | 0 |
| Headache | 13 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.1) ] Ocular Adverse Reactions [see Warnings and Precautions (5.2) ] Stomatitis [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥20%), including laboratory abnormalities, in patients with: EGFR-mutated NSCLC were stomatitis, nausea, alopecia, fatigue, decreased hemoglobin, decreased lymphocytes, constipation, increased calcium, increased AST, decreased white blood cell count, increased lactate dehydrogenase, musculoskeletal pain, decreased appetite, increased ALT, and rash. ( 6.1 ) TNBC were stomatitis, increased amylase, nausea, alopecia, decreased hemoglobin, decreased white blood cells, constipation, decreased calcium, decreased lymphocytes, fatigue, decreased neutrophils, increased ALT, increased AST, dry eye, keratitis, decreased albumin, vomiting, musculoskeletal pain, decreased sodium, and increased blood alkaline phosphatase. ( 6.1 ) HR-positive, HER2-negative breast cancer were stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased ALT, keratitis, increased AST, and increased alkaline phosphatase.
Source: FDA drug label, Daiichi Sankyo Inc., effective May 27, 2026 (SPL set 2950227c-6230-4ca4-a135-46e44d9424a0), via openFDA; the full label on DailyMed
What do FAERS reports show?
639 reports list datopotamab deruxtecan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 138 are coded as a death and 115 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Datopotamab deruxtecan: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions